MSKai is a medical software that helps clinicians by automatically identifying, measuring, and reporting features of the lumbar spine from T2 weighted MRI images. It supports radiologists and spine surgeons by providing reliable, repeatable quantitative assessments that can be reviewed and confirmed for clinical use, improving workflow efficiency.
Intended Use
MSKai is an image identification, post-processing, measurement, and reporting software tool for quantitative measurement of lumbar spine from previously-acquired T2 weighted MRI images in patients aged 18 and above.
Technology
MSKai utilizes a mask region-based convolutional neural network to perform segmentation and measurement of lumbar spine features on MRI. The outputs require user confirmation and are intended for clinical workflow support, not diagnostic decisions.
Performance
The device was validated with a standalone software performance study on 238 MRI lumbar spine cases from multiple sites and scanner manufacturers. Segmentation accuracy and measurement errors met predefined acceptance criteria, showing performance comparable to expert ground truth. Testing data sets for training and validation were independent with high reliability across patient demographics.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/22/2024
8 months - 2
FDA Approval
12/16/2024
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